SIST EN ISO 14644-2:2016
(Main)Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration (ISO 14644-2:2015)
Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration (ISO 14644-2:2015)
This part of ISO 14644 specifies minimum requirements for a monitoring plan for cleanroom or clean
zone performance related to air cleanliness by particle concentration, based upon parameters that
measure or affect airborne particle concentration.
This part of ISO 14644 does not address condition monitoring of aspects such as vibration or general
maintenance of the engineering systems. It does not provide for monitoring of particle populations
that are outside the specified lower threshold particle-size range, 0,1 μm to 5 μm. Concentrations of
ultrafine particles (particles smaller than 0,1μm) will be addressed in a separate standard.
Reinräume und zugehörige Reinraumbereiche - Teil 2: Überwachung zum Nachweis der Reinraumleistung bezüglich Luftreinheit anhand der Partikelkonzentration (ISO 14644-2:2015)
Dieser Teil der ISO 14644 legt Anforderungen an die regelmäßige Prüfung eines Rein¬raumes oder reinen Bereiches zum Nachweis der fortlaufenden Übereinstimmung mit ISO 14644-1 hinsichtlich der bezeichneten Klassifizierung der Partikelreinheit der Luft fest.
Diese Anforderungen beziehen sich auf die in ISO 14644-1 beschriebene Prüfung zur Klassifizierung eines Reinraumes oder eines reinen Bereiches.
Darüber hinaus werden zusätzliche Prüfungen festgelegt (5.2), die nach den Anforderungen dieses Teils von ISO 14644 durchzuführen sind.
Dieser Teil der ISO 14644 legt außerdem Anforderungen an die Überwachung eines Reinraumes oder reinen Bereiches zum Nachweis der fortlaufenden Übereinstimmung mit ISO 14644-1 hinsichtlich der bezeich¬neten Klassifizierung der Partikelreinheit der Luft fest.
Salles propres et environnements maîtrisés apparentés - Partie 2: Surveillance du maintien des performances de la salle propre pour la propreté particulaire de l'air (ISO 14644-2:2015)
ISO 14644-2:2015 spécifie les exigences minimales d'un plan de surveillance des performances d'une salle propre ou d'une zone propre en lien avec la propreté particulaire de l'air, d'après des paramètres qui mesurent ou modifient la concentration de particules en suspension dans l'air.
ISO 14644-2:2015 ne traite pas de la surveillance de l'état dans lequel se trouvent d'autres aspects tels que les vibrations ni de la maintenance générale des systèmes techniques. Elle ne traite pas de la surveillance des populations de particules dont le seuil inférieur se situe en dehors de l'étendue granulométrique de référence de 0,1 µm à 5 µm. Les concentrations de particules ultrafines (plus petites que 0,1 µm) seront traitées dans une norme séparée.
Čiste sobe in podobna nadzorovana okolja - 2. del: Nadzor za dokazovanje lastnosti čistih sob v povezavi s čistostjo zraka na osnovi koncentracije delcev (ISO 14644-2:2015)
Ta del standarda ISO 14644 določa minimalne zahteve za načrt nadzora lastnosti čiste sobe ali čistega območja v zvezi s čistostjo zraka na osnovi koncentracije delcev, ki temelji na parametrih za merjenje ali vplivanje na koncentracijo delcev v zraku.
Ta del standarda ISO 14644 ne obravnava nadzora stanja z vidika vibracij ali splošnega vzdrževanja inženirskih sistemov. Standard ne zajema nadzora populacij delcev, ki so zunaj določenega mejnega razpona velikosti delcev od 0,1 μm do 5 μm. Koncentracije ultra finih delcev (delcev, manjših od 0,1 μm) bodo obravnavane v ločenem standardu.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 14644-2:2016
01-marec-2016
1DGRPHãþD
SIST EN ISO 14644-2:2001
ýLVWHVREHLQSRGREQDQDG]RURYDQDRNROMDGHO 1DG]RU]DGRND]RYDQMH
ODVWQRVWLþLVWLKVREYSRYH]DYLVþLVWRVWMR]UDNDQDRVQRYLNRQFHQWUDFLMHGHOFHY
,62
Cleanrooms and associated controlled environments - Part 2: Monitoring to provide
evidence of cleanroom performance related to air cleanliness by particle concentration
(ISO 14644-2:2015)
Reinräume und zugehörige Reinraumbereiche - Teil 2: Überwachung zum Nachweis der
Reinraumleistung bezüglich Luftreinheit anhand der Partikelkonzentration (ISO 14644-
2:2015)
Salles propres et environnements maîtrisés apparentés - Partie 2: Surveillance du
maintien des performances de la salle propre pour la propreté particulaire de l'air (ISO
14644-2:2015)
Ta slovenski standard je istoveten z: EN ISO 14644-2:2015
ICS:
13.040.35 Brezprašni prostori in Cleanrooms and associated
povezana nadzorovana controlled environments
okolja
SIST EN ISO 14644-2:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN ISO 14644-2:2016
---------------------- Page: 2 ----------------------
SIST EN ISO 14644-2:2016
EN ISO 14644-2
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2015
EUROPÄISCHE NORM
ICS 13.040.35 Supersedes EN ISO 14644-2:2000
English Version
Cleanrooms and associated controlled environments - Part
2: Monitoring to provide evidence of cleanroom
performance related to air cleanliness by particle
concentration (ISO 14644-2:2015)
Salles propres et environnements maîtrisés apparentés Reinräume und zugehörige Reinraumbereiche - Teil 2:
- Partie 2: Surveillance du maintien des performances Überwachung zum Nachweis der Reinraumleistung
de la salle propre pour la propreté particulaire de l'air bezüglich Luftreinheit anhand der
(ISO 14644-2:2015) Partikelkonzentration (ISO 14644-2:2015)
This European Standard was approved by CEN on 27 November 2015.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14644-2:2015 E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 14644-2:2016
EN ISO 14644-2:2015 (E)
Contents Page
European foreword . 3
2
---------------------- Page: 4 ----------------------
SIST EN ISO 14644-2:2016
EN ISO 14644-2:2015 (E)
European foreword
This document (EN ISO 14644-2:2015) has been prepared by Technical Committee ISO/TC 209
"Cleanrooms and associated controlled environments" in collaboration with Technical Committee
CEN/TC 243 “Cleanroom technology” the secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by June 2016, and conflicting national standards shall be
withdrawn at the latest by June 2016.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
This document supersedes EN ISO 14644-2:2000.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 14644-2:2015 has been approved by CEN as EN ISO 14644-2:2015 without any
modification.
3
---------------------- Page: 5 ----------------------
SIST EN ISO 14644-2:2016
---------------------- Page: 6 ----------------------
SIST EN ISO 14644-2:2016
INTERNATIONAL ISO
STANDARD 14644-2
Second edition
2015-12-15
Cleanrooms and associated controlled
environments —
Part 2:
Monitoring to provide evidence of
cleanroom performance related to air
cleanliness by particle concentration
Salles propres et environnements maîtrisés apparentés —
Partie 2: Surveillance du maintien des performances de la salle propre
pour la propreté particulaire de l’air
Reference number
ISO 14644-2:2015(E)
©
ISO 2015
---------------------- Page: 7 ----------------------
SIST EN ISO 14644-2:2016
ISO 14644-2:2015(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2015, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2015 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 14644-2:2016
ISO 14644-2:2015(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Creating, implementing and maintaining a monitoring plan . 2
4.1 Principle . 2
4.2 Risk assessment . 2
4.3 Monitoring plan . 3
4.4 Calibration . 3
4.5 Review and approval. 4
4.6 Response to a deviation during monitoring . 4
5 Periodic classification of air cleanliness by particle concentration .4
Annex A (informative) Matters to consider when developing a monitoring plan .5
Annex B (informative) Considerations for setting alert and action levels .9
Bibliography .14
© ISO 2015 – All rights reserved iii
---------------------- Page: 9 ----------------------
SIST EN ISO 14644-2:2016
ISO 14644-2:2015(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 209, Cleanrooms and associated controlled
environments.
This second edition cancels and replaces the first edition (ISO 14644-2:2000), which has been
technically revised throughout.
ISO 14644 consists of the following parts, under the general title Cleanrooms and associated controlled
environments:
— Part 1: Classification of air cleanliness by particle concentration
— Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle
concentration
— Part 3: Test methods
— Part 4: Design, construction and start-up
— Part 5: Operations
— Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
— Part 8: Classification of air cleanliness by chemical concentration (ACC)
— Part 9: Classification of surface cleanliness by particle concentration
— Part 10: Classification of surface cleanliness by chemical concentration
Attention is also drawn to ISO 14698, Cleanrooms and associated controlled environments — Bio-
contamination control:
— Part 1: General principles and methods
— Part 2: Evaluation and interpretation of bio-contamination data
iv © ISO 2015 – All rights reserved
---------------------- Page: 10 ----------------------
SIST EN ISO 14644-2:2016
ISO 14644-2:2015(E)
Introduction
This revision of ISO 14644-2 emphasizes the need to consider a monitoring strategy in addition to
the initial or periodic execution of the classification of a cleanroom or clean zone in accordance with
ISO 14644-1:2015, 5.1. The monitoring activity provides a continuing flow of data over time, thereby
providing a more detailed view of the performance of the installation.
Potential benefits gained from monitoring are
— faster response to adverse events and conditions,
— ability to develop trends from data over time,
— integration of data from multiple instruments,
— enhanced knowledge of installation and process, which allows for more effective risk assessment, and
— improved control of operational costs and product losses.
ISO 14644-2 specifies the requirements of a monitoring plan, based on risk assessment of the intended
use. The data obtained provide evidence of cleanroom or clean zone performance related to air
cleanliness by particle concentration.
In some circumstances, relevant regulatory agencies may impose supplementary policies, requirements
or restrictions. In such situations, appropriate adaptations of the monitoring procedures may be
required. After a monitoring plan is initially established and implemented, it may be necessary to
revise the plan when significant changes are made to the installation or process requirements. It is also
prudent to conduct periodic reviews of a monitoring plan based on data obtained and experience in use.
© ISO 2015 – All rights reserved v
---------------------- Page: 11 ----------------------
SIST EN ISO 14644-2:2016
---------------------- Page: 12 ----------------------
SIST EN ISO 14644-2:2016
INTERNATIONAL STANDARD ISO 14644-2:2015(E)
Cleanrooms and associated controlled environments —
Part 2:
Monitoring to provide evidence of cleanroom performance
related to air cleanliness by particle concentration
1 Scope
This part of ISO 14644 specifies minimum requirements for a monitoring plan for cleanroom or clean
zone performance related to air cleanliness by particle concentration, based upon parameters that
measure or affect airborne particle concentration.
This part of ISO 14644 does not address condition monitoring of aspects such as vibration or general
maintenance of the engineering systems. It does not provide for monitoring of particle populations
that are outside the specified lower threshold particle-size range, 0,1 µm to 5 µm. Concentrations of
ultrafine particles (particles smaller than 0,1µm) will be addressed in a separate standard.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 14644-1:2015, Cleanrooms and associated controlled environments — Part 1: Classification of air
cleanliness by particle concentration
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 14644-1 and the following apply:
3.1
test
procedure undertaken in accordance with a defined method to determine the performance of an
installation or an element thereof
3.2
monitoring
observations made by measurement in accordance with a defined method and plan to provide evidence
of the performance of an installation
Note 1 to entry: Monitoring may be continuous, sequential or periodic; and if periodic, the frequency shall be
specified.
Note 2 to entry: This information may be used to detect trends in operational state and to provide process support.
3.3
action level
level of a parameter set by the user which, when exceeded, requires immediate intervention, including
investigation of cause, and corrective action
© ISO 2015 – All rights reserved 1
---------------------- Page: 13 ----------------------
SIST EN ISO 14644-2:2016
ISO 14644-2:2015(E)
3.4
alert level
level of a parameter set by the user giving early warning of a drift from normal conditions, which, when
exceeded, should result in increased attention or corrective action
4 Creating, implementing and maintaining a monitoring plan
4.1 Principle
In order to gain assurance that a cleanroom or clean zone is performing adequately by delivering
the required control of air cleanliness by particle concentration, a monitoring plan shall be created,
implemented and maintained.
A monitoring plan shall take into account the level of air cleanliness required, critical locations and
performance attributes of the cleanroom or clean zone that affect the performance of the installation. The
following steps shall be included in the creation, implementation and maintenance of the monitoring plan:
— use appropriate risk assessment tools to understand, evaluate and document the risk of adverse
contamination events;
— develop a written monitoring plan;
— review and approve the plan;
— implement the plan by performing the monitoring;
— analyse the data derived from the monitoring activity, undertake trend analysis where appropriate
and report performance;
— implement and document actions or corrective actions required;
— undertake periodic review of the monitoring plan.
The concentration of airborne particles measured under a monitoring plan may be higher than the
concentration observed during at-rest classification. The observed values may fluctuate considerably
due to factors such as, but not limited to, the number of personnel present, the airflow rate, ventilation
effectiveness, the operation of instruments or machinery, and activities in adjacent spaces.
For processes that inherently produce particles as part of the process and where these particles are
not a threat to the process or product, it may be appropriate to rely on periodic at-rest classification,
or operational classification of simulated operations, rather than monitoring of airborne particles in
operation. Other performance and cleanliness attributes may still be required to be monitored.
4.2 Risk assessment
Risk assessment is a systematic process of identification of hazards and the analysis and evaluation of
risks associated with exposure to those hazards.
A risk assessment shall be undertaken in order to
— develop a monitoring plan by determining factors that may affect the ability to maintain the agreed
air cleanliness by particle concentration of the cleanroom or clean zone, and
— determine the monitoring requirements to provide evidence of performance.
For guidance on what to consider when undertaking a risk assessment, see informative Annex A.
2 © ISO 2015 – All rights reserved
---------------------- Page: 14 ----------------------
SIST EN ISO 14644-2:2016
ISO 14644-2:2015(E)
4.3 Monitoring plan
4.3.1 The monitoring plan shall take into account the output from the risk assessment.
When developing the monitoring plan, the factors described in 4.3.2 to 4.3.13 shall be included as a
minimum.
4.3.2 Listing and justification of all the parameters to be monitored, including those that may affect the
airborne particle concentration.
4.3.3 Description and justification of measurement methods. For further guidance on considerations
when developing a monitoring plan, see informative Annex A.
4.3.4 Accuracy, maintenance and calibration of monitoring instrumentation.
4.3.5 Identification and justification of selected monitoring locations. Monitoring locations shall be
defined in three dimensions.
4.3.6 Identification and justification of monitoring acceptance criteria or limits, including
establishment of a single alarm level, or a dual alarm approach of alert and action levels. The minimum
requirement is that a single alarm action level is established. Additionally, an alarm alert level can be
established to provide early warning of performance deviation. For further guidance on setting alert and
action levels, see informative Annex B.
4.3.7 Specification of the response required should the data fall outside the specified limits.
4.3.8 The need for and frequency of periodic cleanroom or clean zone air cleanliness classification by
particle concentration in accordance with ISO 14644-1:2015, 5.1.
4.3.9 The format for recording data.
4.3.10 The methods, including statistical methods to be used for data trending or other appropriate
analysis.
4.3.11 The reporting requirements.
4.3.12 The policy and media to be used for record retention.
4.3.13 The frequency of review of the monitoring plan.
NOTE Monitoring plans are reviewed periodically; and based on the knowledge gained about the cleanroom
or clean zone, the monitoring programme is revised.
4.4 Calibration
Instrumentation used for monitoring shall be adequate to perform the monitoring operations required,
shall have a valid calibration certificate, and shall meet current accepted practices for the frequency
and method of calibration.
In particular for airborne particle counters, the frequency and method of calibration should be based
upon current accepted practice as specified in ISO 21501-4.
NOTE Some particle counters cannot be calibrated to all of the required tests in ISO 21501-4. If this is the
case, record the decision to use the counter in the monitoring plan.
© ISO 2015 – All rights reserved 3
---------------------- Page: 15 ----------------------
SIST EN ISO 14644-2:2016
ISO 14644-2:2015(E)
4.5 Review and approval
The completed plan shall be reviewed and approved.
4.6 Response to a deviation during monitoring
If monitoring results exceed the specified limit(s), an investigation shall be conducted to determine
cause, and remedial action taken as required.
If the remedial action requires significant changes to the installation and/or its operation, then the
classification test according to ISO 14644-1 shall be undertaken. The monitoring plan shall also be
reviewed as a result of the changes to the installation and/or its operation.
When the desired classification has been achieved, monitoring may be resumed.
5 Periodic classification of air cleanliness by particle concentration
Periodic classification testing shall be undertaken annually in accordance with ISO 14644-1. This
frequency can be extended based on risk assessment, the extent of the monitoring system, and data
that are consistently in compliance with acceptance limits or levels defined in the monitoring plan.
NOTE ISO 14644-3 specifies ancillary tests related to other aspects of cleanroom performance such as
pressure difference, airflow, etc.
4 © ISO 2015 – All rights reserved
---------------------- Page: 16 ----------------------
SIST EN ISO 14644-2:2016
ISO 14644-2:2015(E)
Annex A
(informative)
Matters to consider when developing a monitoring plan
A.1 Risk assessment considerations
A.1.1 Selection of an appropriate risk assessment tool
Risk assessment can be undertaken using a number of tools – separately or in combination – including
but not limited to
— HACCP,
— FMEA / FMECA,
— PHA,
— FTA, and
— HAZOP.
A.1.2 Definition of required performance and operating conditions that may need to be
monitored
These can be factors such as
— understanding the contamination sources and their impact on the activity in the cleanroom or clean
zone at critical locations or at locations representative of the general air cleanliness in a cleanroom
or clean zone,
— performance of the installation that might affect the cleanliness levels such as pressure differential,
airflow uniformity, airflow volume, ventilation effectiveness, temperature, relative humidity,
— normal and energy-saving set-back mode,
— at-rest or operational states, and
— occupancy and level of activity, such as change of shift.
A.2 General considerations
A.2.1 The general matters described in A.2.2 to A.2.21 should be considered when developing a
monitoring plan.
A.2.2 The measurement technique, including the selection of manual and/or automated monitoring.
A.2.3 The resolution, accuracy and calibration requirements of the measurement system including, in
the case of airborne particle counters, the efficiency and limitations of the collection system.
A.2.4 The location of monitoring system components, including requirements for access for
maintenance and calibration.
© ISO 2015 – All rights reserved 5
---------------------- Page: 17 ----------------------
SIST EN ISO 14644-2:2016
ISO 14644-2:2015(E)
A.2.5 Instrument or sample probe location, configuration and orientation.
A.2.6 Identification of frequency of measurement or sampling in order to detect deviation events.
A.2.7 Consideration of issues that may influence the monitoring system or the results obtained, such as
(but not limited to) temperature, humidity, cleaning procedures and agents, fumigation agents, product
materials or process hazards and sources of potential convection currents in the air due to heated surfaces.
A.2.8 Consideration of any potential adverse impact of the sampling system on the process or the
process environment (e.g. possible effects of the extraction of the air-sample volume required by a
particle counter on small enclosed environments).
A.2.9 The results of any airflow visualization studies such as “smoke studies,” computer airflow
modelling simulations or other studies.
A.2.10 Understanding the ventilation effectiveness in the cleanroom or clean zone, as might be affected
by rate of air exchanges, recovery or clean-up time studies, or any other method to understand the
potential rate of removal of airborne particles.
A.2.11 Extent and/or frequency of cleaning or maintenance procedures and their impact on airborne
particle levels, both during execution and immediately after completion of the procedure.
A.2.12 Consideration of process-related events that may affect environmental conditions at monitoring
locations. Such events may include (but are not limited to) dismantling, cleaning and reassembly of
equipment, whether as part of the process cycle or as an element of maintenance work.
NOTE It may be useful to include within the monitoring plan provisions for monitoring the recovery time at
the conclusion of such refitting, prior to resuming normal operations.
A.2.13 Typical positions and movements of personnel during the critical operational periods.
A.2.14 Expectations for the number of personnel active in the cleanroom or clean zone, the nature of
their occupation and the duration of their activities.
A.2.15 Assessment of the impact of equipment-generated changes to airflow patterns.
A.2.16 Assessment of the potential for equipment-generated particle sources. Examples include particles
generated from abrasion of surfaces on moving conveyor systems, and processes such as sealing of glass
ampoules and radio frequency (RF) welding of tubing.
A.2.17 Data logging and data management, including data integrity, storage and retrieval
NOTE In some industries the storage and integrity of data are specifically regulated.
A.2.18 Establishment of suitable techniques for the evaluation of raw data, assessment of trends, and
production of reports.
A.2.19 Definition of acceptance criteria and establishment of a single alarm level, or a dual approach of
alert and action levels.
A.2.20 Requirements for commissioning and testing of the monitoring system(s).
A.2.21 Requirements for maintenance of the monitoring system(s).
6 © ISO 2015 – All rights reserved
---------------------- Page: 18 ----------------------
SIST EN ISO 14644-2:2016
ISO 14644-2:2015(E)
A.3 Pressure differential monitoring
A.3.1 The additional aspects described in A.3.2 to A.3.5 should be considered for specifying monitoring
systems for differential pressures in cleanrooms or clean zones.
A.3.2 The method of minimising or managing fluctuations caused by disturbances such as door
openings or intermittent operation of local exhaust systems. A common method is the introduction of
time delays on alarms.
A.3.3 Selection of a pressure-measurement reference principle (measurement of differential pressure
between rooms or spaces, or measurement of differential against a common reference pressure).
A.3.4 Establishment of alert and action levels that are sensitive to normal pressure fluctuations due to
factors such as wind effects on buildings, the opening and closing of doors and other factors.
A.3.5 The pressure differential may be monitored by periodic observation or by automated
instrumentation.
A.4 Airborne particle monitoring system
A.4.1 The additional aspects described in A.4.2 to A.4.6 should be considered for specifying real-time
airborne particle counting systems.
A.4.2 The configuration of the system based on eva
...
SLOVENSKI STANDARD
oSIST prEN ISO 14644-2:2011
01-april-2011
ýLVWHVREHLQSRGREQDQDG]RURYDQDRNROMDGHO 6SHFLILNDFLMH]DQDG]RULQ
SHULRGLþQHSUHVNXVH]DGRND]RYDQMHVWDOQHVNODGQRVWL],62 ,62',6
Cleanrooms and associated controlled environments - Part 2: Specifications for
monitoring and periodic testing to prove continued compliance with ISO 14644-1
(ISO/DIS 14644-2:2010)
Reinräume und zugehörige Reinraumbereiche - Teil 2: Festlegungen für die
Überwachung und periodische Prüfung zum Nachweis der fortlaufenden
Übereinstimmung mit ISO 14644-1 (ISO/DIS 14644-2:2010)
Salles propres et environnements maîtrisés apparentés - Partie 2: Exigences pour la
surveillance et les contrôles périodiques en vue de démontrer le maintien de la
conformité avec l'ISO 14644-1 (ISO/DIS 14644-2:2010)
Ta slovenski standard je istoveten z: prEN ISO 14644-2
ICS:
13.040.35 Brezprašni prostori in Cleanrooms and associated
povezana nadzorovana controlled environments
okolja
oSIST prEN ISO 14644-2:2011 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
oSIST prEN ISO 14644-2:2011
---------------------- Page: 2 ----------------------
oSIST prEN ISO 14644-2:2011
EUROPEAN STANDARD
DRAFT
prEN ISO 14644-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2010
ICS 13.040.35 Will supersede EN ISO 14644-2:2000
English Version
Cleanrooms and associated controlled environments - Part 2:
Specifications for monitoring and periodic testing to prove
continued compliance with ISO 14644-1 (ISO/DIS 14644-
2:2010)
Salles propres et environnements maîtrisés apparentés - Reinräume und zugehörige Reinraumbereiche - Teil 2:
Partie 2: Exigences pour la surveillance et les contrôles Festlegungen für die Überwachung und periodische
périodiques en vue de démontrer le maintien de la Prüfung zum Nachweis der fortlaufenden Übereinstimmung
conformité avec l'ISO 14644-1 (ISO/DIS 14644-2:2010) mit ISO 14644-1 (ISO/DIS 14644-2:2010)
This draft European Standard is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical Committee
CEN/TC 243.
If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations which
stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other language
made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to
provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2010 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN ISO 14644-2:2010: E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
oSIST prEN ISO 14644-2:2011
prEN ISO 14644-2:2010 (E)
Contents Page
Foreword .3
2
---------------------- Page: 4 ----------------------
oSIST prEN ISO 14644-2:2011
prEN ISO 14644-2:2010 (E)
Foreword
This document (prEN ISO 14644-2:2010) has been prepared by Technical Committee ISO/TC 209
"Cleanrooms and associated controlled environments" in collaboration with Technical Committee CEN/TC 243
“Cleanroom technology” the secretariat of which is held by BSI.
This document is currently submitted to the parallel Enquiry.
This document will supersede EN ISO 14644-2:2000.
Endorsement notice
The text of ISO/DIS 14644-2:2010 has been approved by CEN as a prEN ISO 14644-2:2010 without any
modification.
3
---------------------- Page: 5 ----------------------
oSIST prEN ISO 14644-2:2011
---------------------- Page: 6 ----------------------
oSIST prEN ISO 14644-2:2011
DRAFT INTERNATIONAL STANDARD ISO/DIS 14644-2
ISO/TC 209 Secretariat: ANSI
Voting begins on Voting terminates on
2010-12-02 2011-05-02
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION • МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ • ORGANISATION INTERNATIONALE DE NORMALISATION
Cleanrooms and associated controlled environments —
Part 2:
Specifications for monitoring and periodic testing to prove
continued compliance with ISO 14644-1
Salles propres et environnements maîtrisés apparentés —
Partie 2: Exigences pour la surveillance et les contrôles périodiques en vue de démontrer le maintien
de la conformité avec l'ISO 14644-1
[Revision of first edition (ISO 14644-2:2000)]
ICS 13.040.35
ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for Standardization (ISO), and
processed under the ISO-lead mode of collaboration as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member bodies for a parallel
five-month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments received, will be
submitted to a parallel two-month approval vote in ISO and formal vote in CEN.
To expedite distribution, this document is circulated as received from the committee
secretariat. ISO Central Secretariat work of editing and text composition will be undertaken at
publication stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.
THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE
REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO BECOME
STANDARDS TO WHICH REFERENCE MAY BE MADE IN NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT, WITH THEIR COMMENTS, NOTIFICATION OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPORTING DOCUMENTATION.
© International Organization for Standardization, 2010
---------------------- Page: 7 ----------------------
oSIST prEN ISO 14644-2:2011
ISO/DIS 14644-2
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall
not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In
the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
Copyright notice
This ISO document is a Draft International Standard and is copyright-protected by ISO. Except as permitted
under the applicable laws of the user’s country, neither this ISO draft nor any extract from it may be
reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic,
photocopying, recording or otherwise, without prior written permission being secured.
Requests for permission to reproduce should be addressed to either ISO at the address below or ISO’s
member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Reproduction may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.
ii © ISO 2010 – All rights reserved
---------------------- Page: 8 ----------------------
oSIST prEN ISO 14644-2:2011
ISO/DIS 14644-2
Contents Page
Foreword .iv
Introduction.v
1 Scope.1
2 Normative references.1
3 Terms and definitions .1
4 Demonstration of continued compliance.2
4.1 Principle .2
4.2 Monitoring and periodic testing plan .2
4.3 Records .3
5 Testing for continued compliance.3
6 Monitoring for continued compliance.5
Annex A (informative) Matters to consider when developing the monitoring aspects of a
"monitoring and periodic testing plan".6
A.1 Airborne particle monitoring system .6
A.2 Pressure differential monitoring.7
A.3 Airflow velocity and volume monitoring.7
© ISO 2010 – All rights reserved iii
---------------------- Page: 9 ----------------------
oSIST prEN ISO 14644-2:2011
ISO/DIS 14644-2
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 14644-2 was prepared by Technical Committee ISO/TC 209, Cleanrooms and associated controlled
environments.
This second edition cancels and replaces in whole the first edition (1999), which has been technically revised.
ISO 14644 consists of the following parts, under the general title Cleanrooms and associated controlled
environments:
Part 1: Classification of air cleanliness by particle concentration
Part 2: Specifications for monitoring and periodic testing to prove continued compliance with ISO
14644-1:XXXX
Part 3: Test methods
Part 4: Design, construction and start-up
Part 5: Operations
Part 6: Vocabulary
Part 7: Separative devices (clean air hoods, gloveboxes, isolators, and mini-environments)
Part 8: Classification of airborne molecular contamination
Part 9: Classification of surface cleanliness by particle concentration
Attention is also drawn to ISO 14698, Cleanrooms and associated controlled environments —
Biocontamination control:
Part 1: General principles and methods
Part 2: Evaluation and interpretation of biocontamination data
iv © ISO 2010 – All rights reserved
---------------------- Page: 10 ----------------------
oSIST prEN ISO 14644-2:2011
ISO/DIS 14644-2
Introduction
This part of ISO 14644 provides a process to prove continued compliance with ISO 14644-1:XXXX and
specifies minimum requirements for testing and monitoring. In any testing plan, consideration should also be
given to the particular operational requirements, risk assessment of the installation, and its use.
Cleanrooms and associated controlled environments provide for the control of airborne particulate
contamination to levels appropriate for accomplishing contamination-sensitive activities. Products and
processes that benefit from the control of airborne contamination include aerospace, microelectronics,
pharmaceuticals, medical devices, healthcare, food and others. Many factors besides airborne particulate
cleanliness should be considered in the design, specification, operation and control of cleanrooms and other
controlled environments.
In some circumstances, relevant regulatory agencies may impose supplementary policies or restrictions. In
such situations, appropriate adaptations of the standard testing procedures may be required.
© ISO 2010 – All rights reserved v
---------------------- Page: 11 ----------------------
oSIST prEN ISO 14644-2:2011
---------------------- Page: 12 ----------------------
oSIST prEN ISO 14644-2:2011
DRAFT INTERNATIONAL STANDARD ISO/DIS 14644-2
Cleanrooms and associated controlled environments —
Part 2:
Specifications for monitoring and periodic testing to prove
continued compliance with ISO 14644-1
1 Scope
This part of ISO 14644 specifies requirements for testing and monitoring of a cleanroom or clean zone to
prove its continued compliance with ISO 14644-1:XXXX for the designated classification of air cleanliness by
particle co
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.